Adding vericiguat to guideline heart-failure therapy for people with decompensated heart failure
Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial
This trial will test whether giving vericiguat, on top of usual guideline-based drugs, helps people with decompensated heart failure seen in the emergency department.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Armed Forces Institute of Cardiology, Pakistan Academic / other |
| Locations | 1 site (Rawalpindi, Punjab Province) |
| Trial ID | NCT07444398 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase 1 trial enrolling 70 patients with decompensated heart failure and reduced ejection fraction who present to the emergency department at a single center in Rawalpindi, Pakistan. Eligible patients have LVEF ≤45% with elevated NT-proBNP and will be randomly assigned by lottery to receive vericiguat or placebo in addition to guideline-directed medical therapy (which may include sacubitril/valsartan). Baseline clinical data, NYHA class, and biomarkers will be recorded and patients will be followed for hospitalizations for heart failure, cardiovascular death, and adverse events. The study tests safety and early clinical outcomes of adding vericiguat in an acute decompensated setting.
Who should consider this trial
Good fit: Ideal candidates are adults with decompensated heart failure, LVEF ≤45%, and markedly elevated NT-proBNP who present to the participating emergency department and can provide informed consent via an attendant.
Not a fit: Patients with low blood pressure (<100 mmHg), concurrent use of nitrates or PDE5 inhibitors, current intravenous inotropes, or implanted LVADs are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding vericiguat could reduce heart-failure hospitalizations and cardiovascular deaths for patients presenting with decompensated HFrEF.
How similar studies have performed: Large trials such as VICTORIA have shown a modest benefit of vericiguat in high‑risk chronic HFrEF, but starting vericiguat acutely in the emergency department for decompensated patients is less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with decompensated heart failure (patients with left ventricular ejection fraction ≤45% presenting with NYHA functional class III-IV symptoms or worsening class II symptoms. Along with elevated natriuretic peptide levels defined as NT-proBNP \>1000 pg/mL in patients with sinus rhythm and \>1600 pg/mL in patients with atrial fibrillation in the absence of alternative causes of biomarker elevation) Exclusion Criteria: * Patients with blood pressure \<100 mmHg; * concurrent or anticipated use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors * use of intravenous inotropes or implantable left ventricular assist devices (on medical record)
Where this trial is running
Rawalpindi, Punjab Province
- Armed Forces Institute of Cardiology. Pakistan — Rawalpindi, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Dr Khawaja Danish Ali, MBBS
- Email: khawajadanishali@gmail.com
- Phone: +923448890893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.